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The USP Controlled Room Temperature is a series of United States Pharmacopeia guidelines for the storage of pharmaceuticals; [1] the relevant omnibus standard is USP 797. [2] [3] Although 100% compliance remains challenging for any given facility, [4] the larger protocol may be regarded as constituting a form of clean room [5] which is included in a suite of best practices.
In United States Pharmacopeia (USP) General Chapter <711> Dissolution, there are four dissolution apparatuses standardized and specified. [6] They are: USP Dissolution Apparatus 1 – Basket (37 °C ± 0.5 °C ) USP Dissolution Apparatus 2 – Paddle (37 °C ± 0.5 °C) USP Dissolution Apparatus 3 – Reciprocating Cylinder (37 °C ± 0.5 °C)
In contrast, ambient temperature is the actual temperature, as measured by a thermometer, of the air (or other medium and surroundings) in any particular place. The ambient temperature (e.g. an unheated room in winter) may be very different from an ideal room temperature. Food and beverages may be served at "room temperature", meaning neither ...
Split pea soup was treated using the Dole aseptic machine at the following dosage: heat time of 140–146 °C (280–290 °F) for 3.53 seconds, hold time of 8.8 seconds, and cooling to 32 °C (90 °F) in 14.0 – 17.0 seconds, compared to the normal processing time of 40–70 minutes at 115–121 °C (240–250 °F). The lack of consumer ...
The USP is published in a combined volume with the National Formulary (a formulary) as the USP-NF. [2] If a drug ingredient or drug product has an applicable USP quality standard (in the form of a USP-NF monograph), it must conform in order to use the designation "USP" or "NF".
Mean kinetic temperature (MKT) is a simplified way of expressing the overall effect of temperature fluctuations during storage or transit of perishable goods. The MKT is used to predict the overall effect of temperature fluctuations on perishable goods. It has more recently been applied to the pharmaceutical industry.
A drug reference standard or pharmaceutical reference standard is a highly characterized material suitable to test the identity, strength, quality and purity of substances for pharmaceutical use and medicinal products.
The most common international unit for the MVTR is g/m 2 /day, or "metric perm". In the USA, g/100in 2 /day is also in use, which is 0.064516 (approximately 1/15) of the value of g/m 2 /day units. Typical rates in aluminium foil laminates may be as low as 0.001 g/m 2 /day, whereas the rate in fabrics can measure up to several thousand g/m 2 /day.